Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Launched by SHANGHAI ZHONGSHAN HOSPITAL · May 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods for guiding treatment decisions in patients who have stable chest pain caused by coronary artery disease. The two methods being compared are CT-FFR and QFR. CT-FFR uses advanced imaging techniques to assess blood flow in the coronary arteries, while QFR is another method that evaluates the severity of blockages in these arteries. The goal is to see if one method is better than the other for helping doctors decide on the best treatment for patients experiencing stable chest pain.

To participate in the study, individuals must be at least 18 years old and have stable chest pain with certain characteristics found during a specific heart scan called a coronary CT angiogram (CCTA). They should have at least one blocked artery that needs further evaluation or treatment. Participants should be able to undergo a procedure called invasive coronary angiography, which helps doctors see the heart's arteries more clearly. This study is not yet recruiting participants, and those with certain health issues, such as severe heart failure or allergies to contrast dye, will not be eligible. If you join the trial, you will be randomly assigned to one of the two treatment groups and monitored throughout the study to assess the outcomes of the different approaches.

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.
• • Able to undergo invasive coronary angiography (ICA)
• • Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.
• Exclusion Criteria:
• General exclusion criteria:
• • Patients with acute coronary syndrome requiring urgent revascularization.
• • Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.
• • Patients with iodine contrast agent allergy.
• • Pregnant or lactating women.
• • Patients with severe congestive heart failure (NYHA III-IV or LVEF \<30%) or acute pulmonary edema.
• • Patients with severe renal insufficiency (creatinine \>150μmol/L or estimated - -glomerular filtration rate calculated by the Cockcroft-Gault formula \<45ml/kg/1.73 m2).
• • Patients with other comorbidities and an expected survival time of less than 1 year.
• • Patients who, for any other reason, are considered by the investigators to be unsuitable for inclusion in the study or unable to complete the study and follow-up.
• Coronary CTA and coronary angiography exclusion criteria:
• • Patients with a body mass index \>35 when undergoing coronary CT testing, resulting in poor CT image quality due to motion artifacts, severe calcification, or inadequate iodine contrast agent filling.
• • Patients with a history of coronary artery bypass grafting (CABG).
• • Target lesions related to acute myocardial infarction.
• • Target lesions involving left main stem disease.
• • Target lesions involving myocardial bridging.
• • Target lesions involving in-stent restenosis.
• • Low-quality angiography due to poor visualization of vascular boundaries or poor iodine contrast agent filling.
• • Excessive overlap of the stenotic segment or severe tortuosity of the target vessel, making QFR calculation impossible.
• • Regen